Under the US FDA, the Center for Drug Evaluation and Research (CDER) has launched the Center for Clinical Trial Innovation (C3TI) to increase clinical trial efficiency.
CDER, a part of the US Food and Drug Administration (FDA) regulates and reviews drugs ensuring its safety and effectiveness. Acting as CDER’s central hub, C3TI will support innovative approaches to clinical trials designed to improve drug development efficiency. It will facilitate communication and collaboration, both internally and externally.
Through C3TI, CDER aims to increase efficient review of drugs under trial, optimize clinical development, improved patient access and inclusion, and enhance communication. The center will also direct a demonstration program to enhance opportunities for sponsors of innovative clinical trials. Initially, the three project areas under the program are:
- Point-of-care or pragmatic trials
- Bayesian analyses
- Trials using selective safety data collection
“CDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need,” said Patrizia Cavazzoni, director of CDER.
“We are eager to build on this foundation by launching C3TI to further spur the adoption of clinical trial innovation across industry and within CDER.”
Through C3TI both external and internal parties can easily access information regarding ongoing clinical trials. Through a coordinated approach, the center hopes to increase engagement, identify resources to support the use of innovative modalities, and identify development programs.
Additionally, it will facilitate sharing the lessons learned across CDER’s existing clinical trial innovation initiatives through communication and collaboration with external parties.
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